An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Device, Auto-injector, SureClick, Enbrel, Etanercept
Eligibility Criteria
Inclusion Criteria: - Diagnosis of rheumatoid arthritis RA subjects 18 years or older Currently taking etanercept in pre-filled syringes for at least 4 weeks Subjects must give written informed consent Subjects must be able to read and write in English Exclusion Criteria: - Subject is not using adequate contraception Subject is pregnant or breast feeding Significant concurrent medical diseases
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single-Arm
Arm Description
Open-lable Single Arm Study
Outcomes
Primary Outcome Measures
To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.
Secondary Outcome Measures
To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects.
To determine the rate of failed drug deliveries (as opposed to device failures).
Full Information
NCT ID
NCT00346294
First Posted
June 27, 2006
Last Updated
January 17, 2020
Sponsor
Amgen
Collaborators
Immunex Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00346294
Brief Title
An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis
Official Title
An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
Collaborators
Immunex Corporation
4. Oversight
5. Study Description
Brief Summary
An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Device, Auto-injector, SureClick, Enbrel, Etanercept
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-Arm
Arm Type
Other
Arm Description
Open-lable Single Arm Study
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Description
Intervention type was to study the drug delivery method.
Primary Outcome Measure Information:
Title
To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.
Time Frame
22 Days
Secondary Outcome Measure Information:
Title
To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects.
Time Frame
22 Days
Title
To determine the rate of failed drug deliveries (as opposed to device failures).
Time Frame
22 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Diagnosis of rheumatoid arthritis
RA subjects
18 years or older
Currently taking etanercept in pre-filled syringes for at least 4 weeks
Subjects must give written informed consent
Subjects must be able to read and write in English Exclusion Criteria: - Subject is not using adequate contraception
Subject is pregnant or breast feeding
Significant concurrent medical diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.enbrel.com/
Description
FDA-approved Drug Labeling
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis
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